DRUG DELIVERY DEVICE WITH FRONT LOADING FEATURE
A drug delivery device adapted to receive a cartridge and hold it in a mounted position is provided, comprising a housing, an expelling assembly, and a front-loaded cartridge holder assembly adapted to receive and hold a cartridge in a mounted state. The assembly comprises cartridge holding means actuatable between a receiving state and a holding state, as well as a user operated actuation sleeve being rotationally actuatable relative to the housing between a loading state and an operational state, such that the cartridge holding means is actuated from the receiving state to the holding state when the actuation sleeve is actuated from the loading state to the operational state. The actuation sleeve is configured to enclose at least a portion of a mounted cartridge and is provided with inspection means allowing at least a portion of an enclosed cartridge portion to be visually inspected.
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The present invention generally relates to a drug delivery device adapted to receive a drug filled cartridge and expel a dose therefrom.
BACKGROUND OF THE INVENTIONIn the disclosure of the present invention reference is mostly made to the treatment of diabetes, however, this is only an exemplary use of the present invention.
The most common type of injection devices adapted to receive a drug filled cartridge and expel a dose therefrom are generally pen formed and utilizes a so-called cartridge holder adapted to receive and mount a cartridge in the device. Correspondingly, most pen-formed drug delivery devices comprises a generally cylindrical cartridge holder for receiving and holding a generally cylindrical drug-filled cartridge in a mounted position, the cartridge comprising a proximally facing and axially displaceable piston, and a main body with a housing in which a drug expelling mechanism is arranged, the mechanism comprising an axially displaceable piston rod adapted to engage the piston of a mounted cartridge to thereby expel a dose of drug from the cartridge. Between the cartridge holder and the main body a connection means is provided allowing a user to remove the cartridge holder from the main body and reattach it when a used cartridge has been exchanged with a new cartridge. The cartridge is in most cases inserted in the cartridge holder by axial movement through a proximal opening. The connection means may be in the form of a threaded connection or a bayonet coupling. Depending on the design of the drug delivery device the piston rod has to be moved proximally (i.e. “reset”) by rotation when an empty cartridge is exchanged with a full cartridge, or the piston rod can be reset by being pushed axially, e.g. by unlocking the piston rod when the cartridge holder is removed from the main body, this as disclosed in e.g. US 2009/0275914 and WO 2011/051366.
Alternatively, the drug delivery device may comprise an integrated (i.e. for the user non-removable) cartridge holder adapted to axially receive a cartridge through a distal opening. Such a device is often named “front loaded”. The cartridge holder may be provided with gripping means adapted to hold and release an axially inserted cartridge.
Having regard to the above, it is an object of the present invention to provide a drug delivery device adapted to receive a drug-filled cartridge in a simple and effective way, the arrangement being both user-friendly, cost-effective and reliable.
DISCLOSURE OF THE INVENTIONIn the disclosure of the present invention, embodiments and aspects will be described which will address one or more of the above objects or which will address objects apparent from the below disclosure as well as from the description of exemplary embodiments.
Thus, in accordance with a first aspect of the invention a drug delivery device is provided comprising a cartridge holder adapted to receive and hold a cartridge in a loaded position, the cartridge holder comprising a distal portion with a distal opening adapted to receive the cartridge, the cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston. The drug delivery device further comprises an expelling assembly adapted to engage and axially displace a piston in a loaded cartridge to thereby expel a dose of drug from the cartridge, and snap locking means acting on a cartridge being inserted in the cartridge holder, the snap locking means having a locked state in which the cartridge is held in the loaded position and an un-locked state in which the cartridge can be removed from the cartridge holder, as well as user operated release means for unlocking the snap locking means to thereby allow a cartridge to be removed from the cartridge holder. The expelling assembly may be arranged in a housing providing an outer shell of a drug delivery device or it may be in the form of an assembly formed integrally with the housing. The cartridge holder may be formed integrally with the housing or be attached. By this arrangement the user can easy and safely insert a cartridge in the cartridge holder. It should be noted that the snap locking means not necessarily provides an absolute lock against movements between the cartridge and cartridge holder. For example, the cartridge may still be allowed to rotate or be pushed proximally, e.g. against a spring force. The drug delivery device may be provided as part of a system in combination with a cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston.
The drug delivery may be provided with first biasing means adapted to engage a loaded cartridge and provide an axial distally directed force thereon, this providing that a loaded cartridge is moved distally and thereby at least partially out of the cartridge holder when the release means is operated to unlocking the snap locking means. The first biasing means may further serve to bias the cartridge into engagement with the snap locking means.
In exemplary embodiments the cartridge holder comprises a distal form-stable opening adapted to axially receive a cartridge. The snap locking means may in both the locked and an un-locked state be arranged proximally of the form-stable distal opening. In this way the risk that protruding locking means jams or get entangled with other objects is minimized just like an uncluttered appearance may support the users' impression of a simple device being correspondingly simple to use.
In an exemplary embodiment the snap locking means comprises a pair of opposed flexible locking arms each having a distal gripping portion adapted to engage a cartridge and being reversibly actuatable between a locked and un-locked state. Each distal gripping portion may comprise an inclined proximal surface adapted to engage a corresponding distal actuation surface on the cartridge holder, whereby movement of the flexible locking arms in the proximal direction results in the distal gripping portions being moved outwards corresponding to their un-locked state. Each distal gripping portion may further comprise an inclined distal surface adapted to engage a corresponding proximal actuation surface on the cartridge holder, whereby movement of the flexible locking arms in the distal direction results in the distal gripping portions being moved inwards corresponding to their locked state. At least one of the actuation surfaces may be in the form of a surface inclined corresponding to the corresponding surfaces on the gripping portion, or an edge surface on which the gripping portion slides. Alternatively, another number of locking arms may be used.
The drug delivery device may be provided with second biasing means for holding the snap locking means in the locked state. The snap locking means may be arranged partly or fully in the locked state when no cartridge is arranged in the cartridge holder, the snap locking means being moved to a receiving state when a cartridge is inserted into the cartridge holder, this allowing the cartridge to be inserted into the cartridge holder and snap into engagement with the snap locking means. The receiving state may correspond to the un-locked state or represent an intermediate state.
In accordance with a second aspect of the invention a drug delivery assembly is provided comprising a cartridge with a cylindrical body portion, a distal outlet portion and an axially displaceable piston, a cartridge holder adapted to receive and hold the cartridge in a loaded position, the cartridge holder comprising a distal portion with a distal opening adapted to receive the cartridge, and an expelling assembly adapted to engage and axially displace a piston in a loaded cartridge to thereby expel a dose of drug from the cartridge. The assembly is further provided with snap locking means arranged on the cartridge for locking a cartridge being inserted in the cartridge holder, the snap locking means having a locked state in which the cartridge is held in the loaded position and an un-locked state in which the cartridge can be removed from the cartridge holder, and user operated release means for unlocking the snap locking means to thereby allow a cartridge to be removed from the cartridge holder.
In an exemplary embodiment the snap locking means is in the form of one or more flexible fingers, e.g. two opposed fingers, extending proximally from the distal end of the cartridge, the fingers being provided with protrusions snapping into engagement with corresponding openings in the cartridge holder. The fingers may be released by simply pressing them inwardly. If the assembly further is provided with biasing means providing a distally directed force, actuation of the fingers will result in the cartridge being automatically pushed out of the cartridge holder when released. A brake may be provided between the cartridge and the cartridge holder preventing that the cartridge will be pushed out too vigorously. Specific brake components may be arranged on the cartridge holder, the cartridge or both.
In accordance with the second aspect of the invention a cartridge is provided comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston, and snap locking means in the form of one or more flexible fingers extending proximally from the distal end of the cartridge, the fingers being provided with protrusions adapted to snap into engagement with corresponding structures in the cartridge holder.
In accordance with a third aspect of the invention a drug delivery assembly is provided comprising a cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston, a cartridge holder adapted to receive and hold the cartridge in a loaded position, the cartridge holder comprising a distal portion with a distal opening adapted to receive the cartridge, an expelling assembly adapted to engage and axially displace a piston in a loaded cartridge to thereby expel a dose of drug from the cartridge, and irreversible snap locking means locking the cartridge being inserted in the cartridge holder. The snapping structures may be provided on either or both of the cartridge and cartridge holder. Such an arrangement would allow the assembly to be used for the manufacture of a pre-filled drug delivery device. An advantage of such a system would be that a drug-filled cartridge, which is normally the most expensive part of a pre-filled drug delivery device, could be inserted in a final step of the manufacturing process.
In accordance with a further aspect of the invention a drug delivery device is provided comprising a cartridge holder adapted to receive and hold a cartridge in a loaded position, the cartridge holder comprising a distal portion with a distal opening adapted to receive the cartridge, the cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston, and an expelling assembly adapted to engage and axially displace a piston in a loaded cartridge to thereby expel a dose of drug from the cartridge. The device further comprises locking means locking a cartridge being inserted in the cartridge holder, the locking means having a locked state in which the cartridge is held in the loaded position and an un-locked state in which the cartridge can be removed from the cartridge holder, as well as user operated release means for unlocking the locking means to thereby allow a cartridge to be removed from the cartridge holder. The device is further provided with biasing means adapted to engage a loaded cartridge and provide an axial distally directed force thereon, this providing that a loaded cartridge is moved distally and thereby at least partially out of the cartridge holder when the release means is operated to unlock the locking means. The biasing means may further serve to bias the cartridge into engagement with the snap locking means.
The above described drug delivery devices in accordance with aspects of the invention may be provided in combination with a cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston, the cartridge holder and the cartridge having cooperating coupling means.
As used herein, the term “drug” is meant to encompass any flowable medicine formulation capable of being passed through a delivery means such as a cannula or hollow needle in a controlled manner, such as a liquid, solution, gel or fine suspension, and containing one or more drug agents. Representative drugs include pharmaceuticals such as peptides (e.g. insulins, insulin containing drugs, GLP-1 containing drugs as well as derivates thereof), proteins, and hormones, biologically derived or active agents, hormonal and gene based agents, nutritional formulas and other substances in both solid (dispensed) or liquid form. In the description of the exemplary embodiments reference will be made to the use of insulin and GLP-1 containing drugs, this including analogues thereof as well as combinations with one or more other drugs. Correspondingly, the term “subcutaneous” delivery is meant to encompass any method of transcutaneous delivery to a subject.
In the following the invention will be further described with reference to the drawings, wherein
In the figures like structures are mainly identified by like reference numerals.
When in the following terms such as “upper” and “lower”, “right” and “left”, “horizontal” and “vertical” or similar relative expressions are used, these only refer to the appended figures and not to an actual situation of use. The shown figures are schematic representations for which reason the configuration of the different structures as well as their relative dimensions are intended to serve illustrative purposes only.
Referring to
Referring to
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Referring to
In the
More specifically,
As shown, the cartridge holder has the same general appearance as a traditional cartridge holder which is detachably coupled to the housing by e.g. a threaded coupling or a bayonet coupling and into which a new cartridge can be received as well as removed through a proximal opening, i.e. it comprises no additional user operated release means such as the opposed protrusions 143 shown in
When it is time to mount a new cartridge the outer tube member is rotated e.g. 15 degrees by which action the gripping shoulders 545 are moved distally and slightly outwards, this allowing the cartridge to be removed. For ease of operation the cartridge may be moved distally a certain distance as the shoulders are moved, e.g. by engagement with the arms forming the gripping shoulders and/or by additional spring means providing a biasing distally directed force.
The mechanical arrangement providing the above-described user-interface, i.e. rotation of the outer tube member moves the gripping shoulders in and out, can be provided in numerous ways. In the
As indicated above, the drug delivery device of
In one embodiment of such a module a display is integrated in the proximal-most release button. Consequently, the display is relatively small and will for a pen-formed device typically be close to circular. Further, to provide a simple user interface and appearance no additional buttons are provided this making it a challenge to recall and display dose history information in a simple, effective and reliable way. In the following examples are, shown for a display adapted to show information in respect of the last dose expelled from the device, i.e. the size of the dose in units of insulin, and the time since it was expelled. Alternatively, other units may be displayed when the device is adapted for other drugs, e.g. mg for a GLP-1 formulation or growth hormone.
As appears especially from
As an alternative to use one or two 7-segment displays a matrix display 620 may be utilized, however, both the display and the corresponding driver are more expensive. In the displays shown in
As a display used for the above-described intended purpose is expected to be watched only a few times every day, the display should be turned on only when needed to save energy. The display may be actuated and controlled either by “inherent” control means already provided and used to set and expel a dose of drug or by additional input means provided only to control the display. The inherent input means for a mechanical-type drug delivery device are typically the dose setting member which mostly is in the form of a rotatable member and the release button which may be arranged at the proximal end of the device as shown in
In an exemplary embodiment a drug delivery device with dose logging feature may be operated in the following way. During normal use of a per se mechanical drug delivery device a user will set a dose using the mechanical display 126 (see
When a user desires to check the dose log a user input has to be provided in order to control the electronics to shift to display mode, i.e. displaying the log information using either a single or two display views as discussed above. A simple and to many intuitive input would be to just press the actuation button to turn on the display, however, if a dose inadvertently has been dialled in a spring driven device this action will release the mechanism and start expelling of drug which indeed is not desirable. To avoid this and still use inherent input means the user may dial up a dose and then dial back the dose to zero, this bringing the electronics in display mode. Alternatively, the delivery device may be provided with input means to be used exclusively for bringing the electronics into display mode. For example, the dose ring member 125 may be pushed forward or pulled backward a slight distance or rotated slightly backwards (by which action the mechanical dose display does not have to be moved correspondingly backwards). Correspondingly, if the logging electronics is provided with a memory for a number of dose events then different combinations of input for the mentioned input types can be used to control the display, e.g. to show data for only the last dose event the user may push forward the dose ring member whereas pulling the member backwards will step the user through log data for previous injections. This mode may then time out or be cancelled by pushing forward the dose ring member. In order to provide the user with information in respect of older log data the display may be provided with additional indicia, e.g. peripheral “5 minutes” segments may each indicate one of 12 memory positions. As a further alternative, the electronic module may be provided with other types of input means, e.g. a motion sensor which would allow a user to turn on the display by shaking or tapping, or a touch sensor integrated in the display as is well known from e.g. smartphones which would allow a user to turn on the display by swiping a finger across the display.
In the description of exemplary embodiments a drug delivery device of the general pen type has been shown, however, the drug delivery device may have other form-factors, e.g. box-formed as the Innovo® device from Novo Nordisk, and may also be provided with a motorized expelling mechanism.
In the above description of the preferred embodiments, the different structures and means providing the described functionality for the different components have been described to a degree to which the concept of the present invention will be apparent to the skilled reader.
The detailed construction and specification for the different components are considered the object of a normal design procedure performed by the skilled person along the lines set out in the present specification.
Claims
1. A drug delivery device adapted to receive a cartridge and hold it in a mounted position, the cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston, the drug delivery device comprising:
- a housing,
- an expelling assembly comprising: a piston rod adapted to engage and axially displace a piston in a mounted cartridge in a distal direction to thereby expel a dose of drug from the cartridge, and a drive assembly adapted to move the piston rod in the distal direction corresponding to a set dose,
- a front-loaded cartridge holder assembly having a central axis and being adapted to receive and hold a cartridge in a mounted state, comprising: cartridge holding means actuatable between: a receiving state in which a cartridge can be received in a proximal direction, and a holding state in which a received cartridge is held in an operational mounted position, a user operated actuation sleeve being rotationally actuatable relative to the housing between a loading state and an operational state,
- wherein the cartridge holding means is actuated from the receiving state to the holding state when the actuation sleeve is actuated from the loading state to the operational state, and
- wherein the actuation sleeve encloses at least a portion of a mounted cartridge, the actuation sleeve comprising inspection means allowing at least a portion of an enclosed cartridge portion to be visually inspected.
2. A drug delivery device as in claim 1, the cartridge holding means comprising one or more distal gripping portions being moved towards the central axis when the cartridge holder is actuated from the receiving state to the holding state, and being moved away from the central axis when the cartridge holder is actuated from the holding state to the receiving state.
3. A drug delivery device as in claim 2, the cartridge holding means comprising one or locking arms each having one of the distal gripping portions, wherein:
- each locking arm is moved proximally when the cartridge holder is actuated from the receiving state to the holding state, and
- each locking arm is moved distally when the cartridge holder is actuated from the holding state to the receiving state.
4. A drug delivery device as in claim 3, wherein the actuation sleeve and the locking arms are operationally coupled to each other such that:
- each locking arm is moved laterally and held in a lateral receiving position when the locking arm is moved distally corresponding to the receiving state, and
- each locking arm is moved centrally and held in a central holding position when the locking arm is moved proximally corresponding to the operational state.
5. A drug delivery device as in claim 3, wherein at least one locking arm comprises one or more openings or is at least partially transparent.
6. A drug delivery device as in claim 3, wherein the actuation sleeve comprises one or more openings or is at least partially transparent, thereby providing the inspection means.
7. A drug delivery device as in claim 3, wherein the cartridge holding means is rotationally coupled to the actuation sleeve.
8. A drug delivery device as in claim 3, wherein the actuation sleeve encloses the distal portion of the cartridge holding means in the operational state.
9. A drug delivery device as in claim 3, wherein the expelling assembly further comprises a coupling mechanism actuatable between:
- a resetting state in which the piston rod can be moved proximally, and
- an operational state in which the drive assembly can drive the piston rod distally but in which the piston rod cannot be moved proximally,
- wherein the coupling is actuated from the resetting state to the operational state when the actuation sleeve is actuated from the loading state to the operational state.
10. A drug delivery device as in claim 9, wherein the actuation sleeve is actuatable from a loading state through an intermediate state to an operational state, wherein:
- the cartridge holder is actuated from the receiving state to the holding state when the actuation sleeve is actuated from the loading state to the intermediate state, and
- the coupling is actuated from the resetting state to the operational state when the actuation sleeve is actuated from the intermediate state to the operational state.
11. A drug delivery device as in claim 9 in combination with a cartridge comprising a cylindrical body portion, a distal outlet portion and an axially displaceable piston, the cartridge being adapted to be received in and hold in the mounted position in the cartridge holder assembly.
12. A drug delivery device as in claim 10, wherein the actuation sleeve axially encloses at least 50% of the length of a mounted cartridge.
13. A method of operating a drug delivery system, comprising:
- providing a cartridge comprising a cylindrical body portion having opposed distal and proximal portions, a distal outlet portion and an axially displaceable piston,
- providing a drug delivery device comprising: a front-loaded cartridge holder adapted to axially receive the cartridge in a proximal direction and hold the cartridge in a loaded position, the cartridge holder being actuatable between a receiving and a holding state, an actuation sleeve comprising inspection means, and an expelling assembly adapted to engage and axially displace the piston in a loaded cartridge,
- inserting a cartridge in the cartridge holder, the actuation sleeve axially enclosing at least 50% of the cartridge length, and
- rotating the actuation sleeve to actuate the cartridge holder from the receiving to the holding state.
14. A method of operating a drug delivery system as in claim 12, further comprising:
- inspecting the inserted cartridge through the actuation sleeve inspection means.
Type: Application
Filed: Jan 25, 2013
Publication Date: Nov 26, 2015
Patent Grant number: 11103640
Applicant: NOVO NORDISK A/S (Bagsvaerd)
Inventor: Morten Soerensen (Ballerup)
Application Number: 14/379,943